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Which companies manufacture nivolumab generically?

See the DrugPatentWatch profile for nivolumab

At this time, there are no generic manufacturers for Nivolumab, which is commercially available under the brand name Opdivo. Nivolumab is a type of immunotherapy drug called a programmed death receptor-1 (PD-1) blocking antibody, used to treat several types of cancer including melanoma, non-small cell lung cancer, and renal cell carcinoma, among others [1].

The patent for Nivolumab, held by Bristol Myers Squibb, is set to expire in 2028 [2]. Once the patent expires, other pharmaceutical companies will be able to manufacture and sell generic versions of Nivolumab. According to DrugPatentWatch.com, there are several companies that have filed for a paragraph IV certification, which is a legal process that allows a generic manufacturer to challenge the patent of a brand-name drug and begin selling a generic version before the patent expires [3]. These companies include, but are not limited to, Mylan Pharmaceuticals, Amneal Pharmaceuticals, and Teva Pharmaceuticals [3]. However, it is important to note that the filing of a paragraph IV certification does not guarantee that a generic version of Nivolumab will be available before 2028.

In summary, as of now, there are no generic manufacturers for Nivolumab, but several companies have filed for a paragraph IV certification to begin selling a generic version once the patent expires in 2028.

Sources:

1. National Cancer Institute. (2021). Nivolumab. Retrieved from <https://www.cancer.gov/about-cancer/treatment/drugs/nivolumab>
2. Bristol Myers Squibb. (2021). Opdivo (nivolumab) Prescribing Information. Retrieved from <https://packageinserts.bms.com/pi/pi_opdivo.pdf>
3. DrugPatentWatch.com. (2021). Nivolumab (Opdivo) Patent Expiration & Generic Entry. Retrieved from <https://www.drugpatentwatch.com/patent/nivolumab-opdivo-patent-expiration-generic-entry/>


Other Questions About Nivolumab :  How does patient s health affect nivolumab treatment length? How does weight impact nivolumab dosing? Can nivolumab dosage be adjusted based on patient s weight?





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